DEXMEDETOMIDINE in NORMAL VAGINAL DELIVERY

Menoufia University

Status and phase: Enrolling; Phase 4

Conditions: Painless Vainal Labour

Treatments: Drug: Bupivacaine Injection; Drug: Dexmedetomidine Injection [Precedex]

Study type: Interventional

Funder types: Other

Identifiers

NCT05840328

11/2022ANET49

Details and patient eligibility

About

compare the effect of intravenous and epidural dexmetomidine as an adjuvant to local anesthetics in epidural labor analgesia in normal labor

Enrollment: 60 estimated patients

Sex: Female

Ages: 19 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Full term (≥ 37 weeks) healthy primigravida parturients ASA2
• with single fetus scheduled for vaginal delivery
• with cephalic presentation
• requesting labor analgesia.

Exclusion criteria

• Allergy to dexmetomidine.(based on previous history)
• Cardiac conduction abnormalities.(all degrees of heart block , tachyarrythmias)
• Twins.
• Malpresentation.
• Preeclampsia or gestational hypertension
• Uncontrolled diabetes HBA1c ≥ 6.5%
• Uncontrolled renal failure
• Uncontrolled liver disease
• Bleeding tendency or coagulopathy.
• Contraindication or patient refusal to epidural block.
• Body mass index ≥ 35.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

plan group

Placebo Comparator group

Description:

bupivacaine will be administered epidurally as a loading dose then epidural continuous infusion with 0.125 % bupivacaine at rate 10 ml will be a maintainance for analgesia .IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml \\hr.

Treatment:

Drug: Bupivacaine Injection

epidural group

Active Comparator group

Description:

10 ml of 0.125 % buoivacaine with 0.5 µg\\ml dexmetomidine as a loading dose then continuous epidural infusion of 0.125% bupivacaine with 0.5µ/ml dexmetomidine at a rate of 10 ml\\hr will be used as maintainance . IV placebo (normal saline) infusion will be connected to each patient at a rate of 10 ml\\hr

Treatment:

Drug: Dexmedetomidine Injection [Precedex]

Drug: Bupivacaine Injection

intravenous group

Active Comparator group

Description:

continuous intravenous dexmetomidine infusion at rate of 0.5 µg / kg / hour in addition to same epidural infusion of 0.125% bupivacaine

Treatment:

Drug: Dexmedetomidine Injection [Precedex]

Drug: Bupivacaine Injection